After plunging from over $2 per share to a low of $1.23 in a couple weeks during June, shares of Resverlogix Corp. (TSX:RVX) are recovering a portion of the losses this week. Tuesday's catalyst was the Calgary-based biotech saying that it received a written response from the U.S. Food and Drug Administration approving the inclusion of U.S. patients in Resverlogix's phase 3 trials of apabetalone.
In a late-stage study dubbed BETonMACE, apabetalone, a selective inhibitor of BET (Bromodomain and ExtraTerminal Domain) proteins, is being used along with standard of care in high-risk cardiovascular disease patients with type 2 diabetes mellitus. The primary endpoint is evaluating the ability of the treatment to result in slower onset of any major adverse cardiac event (MACE) compared to placebo. MACE is defined as cardiovascular death, non-fatal myocardial infarction (surviving a heart attack) or stroke.
The trial is being conducted across sites worldwide, including the first patient being randomized in Taiwan earlier this month and Russia before that. The trial began in November 2015 following the European Medicines Agency clearing apabetalone for phase 3 research. So far, over 70% of the 1,600-patient target has been enrolled. With the trial length, some patients have been treated for about 80 weeks, which is more than three times longer than patients were treated in any other study of apabetalone.
This speaks volumes for safety, although it should be noted that the data remains blinded to all.
On four occasions, an independent Data and Safety Monitoring Board has reviewed data from the BETonMACE study, delivering a positive recommendation for the trial to continue in each instance.
After closing last week at $1.31, shares of RVX ran to $1.43 on Monday and have touched as high as $1.70 in Tuesday morning trading before slipping back to $1.57 just after 11 a.m. EDT.
